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Survey the effect of intra-silicon oil Triamcinolone acetonide on macular anatomy after vitrectomy for rhegmatogenous retinal detachment

Protocol summary

Study aim
Determination of effect of intra-silicon oil Triamcinolone acetonide injection after vitrectomy in patients with rhegmatogenous retinal detachment on reduction of retinal atrophy Determination of effect of intra-silicon oil Triamcinolone acetonide injection after vitrectomy in patients with rhegmatogenous retinal detachment on reduction of second retinal detachment Determination of effect of intra-silicon oil Triamcinolone acetonide injection after vitrectomy in patients with rhegmatogenous retinal detachment on best corrected visual acuity improvement
Design
Randomized control trial, two arm parallel group randomized trial with double blinded outcome assessment. Randomization was done with concealed blocked randomization chart.
Settings and conduct
The patients participated in investigation, will be evaluated before operation,1 ,3 and 6 months after operation by best corrected visual acuity, IOP and macula OCT. Except investigator, no one is aware of specified codes and its meanings.
Participants/Inclusion and exclusion criteria
Including criteria: age more than 18 year old, rhegmatogenous retinal detachment including macula which lasts about 1month since initial symptoms Excluding criteria: aphakia, pseudophakia with previous complicated cataract surgery, previous retinal surgery, diabetic retinopathy, axial length more than 26 mm and less than 20 mm, need to retinotomy, abnormal optic disk, glucoma or IOP more than 21 mm Hg before operation, abnormal retina, tractional retinal datachment, vitreous hemorrhage, history of anti-VEGF injection, post operative complications
Intervention groups
In intervention group, at the end of vitrectomy and silicon oil injection operation, Triamcinolone acetonide by dose of 1 mg/0.05 cc will be injected.
Main outcome variables
Evaluation about effect on rerinal atrophy, retinal second detachment and best corrected visual acuity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200620047837N1
Registration date: 2020-08-08, 1399/05/18
Registration timing: registered_while_recruiting

Last update: 2020-08-08, 1399/05/18
Update count: 0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Mohammad Hossein Nowroozzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 1779
Email address
nowroozzadeh@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-27, 1399/04/07
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of intra-silicon oil Triamcinolone acetonide on macular anatomy after vitrectomy for rhegmatogenous retinal detachment
Public title
Effect of Intra-silicon oil Triamcinolone acetonide on macular anatomy in rhegmatogenous retinal detachment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 year old Rhegmatogenous retinal detachment involving macula Need for vitrectomy surgery and silicon oil injection Less than 1month since symptoms initiation
Exclusion criteria:
Aphakia Pseudophakia with previous complicated catatract surgery Any complication during previous occular surgeries Previous scleral buckling surgery, pneumatic surgery and vitrectomy surgery Diabetic retinopathy Axial length more than 26 mm or less than 20 mm Abnormal optic disk Need to retinotomy History of uveitis Glucoma or IOP more than 21 mm Hg before operation Abnormal retina such as coloboma and choroidal detachment Tractional retinal detachment Vitreous hemorrhage History of anti-VEGF injection
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by blocked method. 6 persons will place in every block equally. Randomization chart will be used as randomization tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants don't have any information about the group they participate in. No information will be registered on operation note and follow up note about injection of Triamcinolone acetonide in both groups. Every patient will be known by a special code witch only the investigator knows that code belongs to which group. Also analizer and evaluator of consequences are unaware about codes and their specification to every group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz university of Medical Sciences central building, Zand Blvd, shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.SUMS.MED.REC.1398.644

Health conditions studied

1

Description of health condition studied
Rhegmatogenous retinal detachment
ICD-10 code
H33.0
ICD-10 code description
Retinal detachment with retinal break

Primary outcomes

1

Description
Macular thickness
Timepoint
Before operatio; 1, 3 and 6 months after operation
Method of measurement
Macular OCT with Heidelberg

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Injection of 1 time Triamcinolone acetonide within sclerotmy site by dose of 1 mg/0.05 cc from 40mg ampoule made by Alborz Darou company at end of vitrectomy and silicon oil injection operation
Category
Treatment - Drugs

2

Description
Control group:Triamcinolone acetonide is not injected. Other procedures are identical to intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Mohammad hosein Nowroozzadeh
Street address
Khalil hospital, Khilil Ave., Mollasadra street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3629 1470
Fax
+98 71 3627 1671
Email
Nowroozzadeh@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghasemi, Y. Pharm.D, PhD
Street address
Shiraz University of Medical Sciences central building, Zand Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
Vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hosein Nowroozzadeh, MD
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili Ave., Mollasadra street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3629 1470
Email
Nowroozzadeh@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammd hosein Nowroozzadeh MD
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili Ave., Mollasadra street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3629 1470
Email
Nowroozzadeh@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hosein Nowroozzadeh, MD
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili Ave., Mollasadra street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3629 1470
Email
Nowroozzadeh@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Due to all gathered data from patients evaluate unknownly, all these informations are sharable totally.
When the data will become available and for how long
6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Evauation of survey and gathering data method
From where data/document is obtainable
Email to Nowroozzadeh@hotmail.com Refer or contact to Poostchi ophthalmology research center dependent on Shiraz university of medical sciences, phone number: 0098 7132302830, Fax: 0098 7132355936
What processes are involved for a request to access data/document
At first contact to Nowroozzadeh@hotmail.com and send your request; then contact to Poostchi ophthalmology research center dependent on Shiraz university of medical sciences, phone number: 0098 7132302830, Fax: 0098 7132355936
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